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Medication adverse events

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https://www.readbyqxmd.com/read/28823033/the-combination-of-mitomycin-induced-blood-cells-with-a-temporary-treatment-of-ciclosporin-a-prolongs-allograft-survival-in-vascularized-composite-allotransplantation
#1
Christian Andreas Radu, Sebastian Fischer, Yannick Diehm, Otto Hetzel, Florian Neubrech, Laura Dittmar, Christian Kleist, Martha Maria Gebhard, Peter Terness, Ulrich Kneser, Jurij Kiefer
BACKGROUND: Vascularized composite allotransplantation (VCA) is a rapidly expanding field of transplantation and provides a potential treatment for complex tissue defects. Peripheral blood mononuclear cells (PBMCs) shortly incubated with the antibiotic and chemotherapeutic agent mitomycin C (MMC) can suppress allogeneic T cell response and control allograft rejection in various organ transplantation models. MMC-incubated PBMCs (MICs) are currently being tested in a phase I clinical trial in kidney transplant patients...
August 19, 2017: Langenbeck's Archives of Surgery
https://www.readbyqxmd.com/read/28823018/prevalence-and-nature-of-potential-drug-drug-interactions-among-kidney-transplant-patients-in-a-german-intensive-care-unit
#2
Julia Amkreutz, Alexander Koch, Lukas Buendgens, Anja Muehlfeld, Christian Trautwein, Albrecht Eisert
Background Complex polypharmacotherapy makes kidney transplant patients vulnerable to drug-drug interactions (DDIs). Objective To study prevalence and nature of potential DDIs (pDDIs) in kidney transplant patients. Setting Internal medicine ICU, University Hospital RWTH Aachen. Method In this retrospective observational study, pDDIs were identified in the first week after transplant from 1999 to 2010. Patients aged at least 18 years with prescription of at least two drugs were included. Patients with incomplete data were excluded...
August 19, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28822668/intrinsic-wave-propagation-of-myocardial-stretch-a-new-tool-to-evaluate-myocardial-stiffness-a-pilot-study-in-patients-with-aortic-stenosis-and-mitral-regurgitation
#3
Cristina Pislaru, Mahmoud M Alashry, Jeremy J Thaden, Patricia A Pellikka, Maurice Enriquez-Sarano, Sorin V Pislaru
BACKGROUND: Left ventricular (LV) filling following atrial contraction generates LV myocardial stretch that propagates from base to apex with a speed proportional to myocardial elasticity. The aim of this study was to test the hypothesis that intrinsic velocity propagation of myocardial stretch (iVP) would be altered in patients with valvular disease and chronic LV pressure overload or volume overload, which may adversely affect mechanical properties of the LV tissue. A second aim was to compare iVP with flow propagation velocity in the chamber...
August 16, 2017: Journal of the American Society of Echocardiography
https://www.readbyqxmd.com/read/28822583/-misuse-and-adverse-effects-of-new-direct-oral-anticoagulants-a-prospective-observational-study-in-patients-admitted-to-an-emergency-unit-of-a-french-university-hospital
#4
Thomas Lafon, Christine Vallejo, Mathilde Hadj, Marie-Laure Laroche, Hélène Geniaux
INTRODUCTION: The use of direct oral anticoagulants (NOAC) is complex: indications, dosage adjustments and precautions. Emergency departments (ED) are increasingly faced with patients receiving NOAC. The aim of this study was to evaluate the misuse and the adverse effects (AE) of NOAC. METHODS: All subjects with NOAC admitted to the Limoges University Hospital ED from 1/8/2013 to 1/4/2014 were included in a prospective observational study. Misuse was identified from the NOAC summary of product characteristics and from the 2014 ANSM guideline (indication, dose, co-medications, age, hepatic and renal function); adverse effects were recorded...
July 19, 2017: Thérapie
https://www.readbyqxmd.com/read/28821915/risk-and-outcomes-of-fracture-in-peripheral-arterial-disease-patients-two-nationwide-cohort-studies
#5
F-L Liu, C-S Lin, C-C Yeh, C-C Shih, Y-G Cherng, C-H Wu, T-L Chen, C-C Liao
Using national insurance claims data of Taiwan, we found that patients with peripheral arterial disease (PAD) had increased risk of fracture during the follow-up period of 2000-2013. History of PAD was also associated with adverse outcomes in hospitalized fracture patients. Prevention strategies were needed in this susceptible population. INTRODUCTION: Limited information was available on the association between PAD and fracture. The purpose of this study is to evaluate fracture risk and post-fracture outcomes in patients with PAD...
August 18, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28821597/a-randomised-controlled-trial-assessing-the-efficacy-of-an-electronic-discharge-communication-tool-for-preventing-death-or-hospital-readmission
#6
Maria J Santana, Jayna Holroyd-Leduc, Danielle A Southern, Ward W Flemons, Maeve O'Beirne, Michael D Hill, Alan J Forster, Deborah E White, William A Ghali
OBJECTIVE: To assess the efficacy of an electronic discharge communication tool (e-DCT) for preventing death or hospital readmission, as well as reducing patient-reported adverse events after hospital discharge. The e-DCT assessed has already been shown to yield high-quality discharge summaries with high levels of patient and physician satisfaction. METHODS: This two-arm randomised controlled trial was conducted in a Canadian tertiary care centre's internal medicine medical teaching units...
August 18, 2017: BMJ Quality & Safety
https://www.readbyqxmd.com/read/28818882/neuropsychiatric-adverse-drug-reactions-in-children-initiated-on-montelukast-in-real-life-practice
#7
Brigitte Benard, Valérie Bastien, Benjamin Vinet, Roger Yang, Maja Krajinovic, Francine M Ducharme
Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy...
August 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28818518/seladelpar-mbx-8025-a-selective-ppar-%C3%AE-agonist-in-patients-with-primary-biliary-cholangitis-with-an-inadequate-response-to-ursodeoxycholic-acid-a-double-blind-randomised-placebo-controlled-phase-2-proof-of-concept-study
#8
David Jones, Pol F Boudes, Mark G Swain, Christopher L Bowlus, Michael R Galambos, Bruce R Bacon, Yvonne Doerffel, Norman Gitlin, Stuart C Gordon, Joseph A Odin, David Sheridan, Markus-Alexander Wörns, Virginia Clark, Linsey Corless, Heinz Hartmann, Mark E Jonas, Andreas E Kremer, George F Mells, Peter Buggisch, Bradley L Freilich, Cynthia Levy, John M Vierling, David E Bernstein, Marek Hartleb, Ewa Janczewska, Fedja Rochling, Hemant Shah, Mitchell L Shiffman, John H Smith, Yun-Jung Choi, Alexandra Steinberg, Monika Varga, Harinder Chera, Robert Martin, Charles A McWherter, Gideon M Hirschfield
BACKGROUND: Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. METHODS: The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid...
August 14, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28818058/evaluation-of-therapy-management-and-outcome-in-takotsubo-syndrome
#9
Nadine Abanador-Kamper, Lars Kamper, Judith Wolfertz, Witali Pomjanski, Anamaria Wolf-Pütz, Melchior Seyfarth
BACKGROUND: To date there is no validated evidence for standardized treatment of patients with Takotsubo syndrome (TTS). Medication therapy after final TTS diagnosis remains unclear. Previous data on patient outcome is ambivalent. Aim of this study was to evaluate medication therapy in TTS and to analyze patient outcome. METHODS: Within an observational retrospective cohort study we analyzed our medical records and included 72 patients with TTS that underwent cardiovascular magnetic resonance imaging (CMR) after a median of 2 days interquartile range (IQR 1-3...
August 17, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28817604/therapeutic-flexible-airway-endoscopy-of-small-children-in-a-tertiary-referral-center-11-years-experience
#10
Wen-Jue Soong, Pei-Chen Tsao, Yu-Sheng Lee, Chia-Feng Yang
OBJECTIVES: Use of therapeutic flexible airway endoscopy (TFAE) is very limited in pediatrics. We report our clinical experiences and long term outcomes of TFAE in small children from a single tertiary referral center. METHODS: This is a retrospective cohort study. Small children with their body weight no more than 5.0 kg who had received TFAE between 2005 and 2015 were enrolled. Demographic information and outcomes were reviewed and analyzed from medical charts and TFAE videos...
2017: PloS One
https://www.readbyqxmd.com/read/28817490/an-open-trial-of-iloperidone-for-mixed-episodes-in-bipolar-disorder
#11
Vivek Singh, Jodi Gonzalez Arnold, Thomas J Prihoda, Melissa Martinez, Charles L Bowden
BACKGROUND: Mixed mood states in bipolar disorder are difficult to treat and when present indicate worse illness trajectories. Several medications are US Food and Drug Administration approved to treat mixed episodes; however, the clinical trials have been short term and rarely reported depression response. METHODS: We conducted a 5-month open-label trial examining the tolerability and efficacy of iloperidone for bipolar disorder mixed episodes. RESULTS: Mania and depression scores significantly improved over the course of the study for study completers (ie, 60%-68% improvement for manic symptoms and 41%-49% for depression symptoms)...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#12
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28817180/preventable-and-mitigable-adverse-events-in-cancer-care-measuring-risk-and-harm-across-the-continuum
#13
Allison Lipitz-Snyderman, David Pfister, David Classen, Coral L Atoria, Aileen Killen, Andrew S Epstein, Christopher Anderson, Elizabeth Fortier, Saul N Weingart
BACKGROUND: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings. METHODS: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28816896/factors-associated-with-adverse-events-in-inpatient-elective-spine-knee-and-hip-orthopaedic-surgery
#14
Dov B Millstone, Anthony V Perruccio, Elizabeth M Badley, Y Raja Rampersaud
BACKGROUND: Orthopaedic procedures for degenerative musculoskeletal conditions (predominantly osteoarthritis and spinal stenosis) represent an increasing burden on the health-care system. These procedures are also associated with adverse event rates and related cost. The objective of this study was to identify risk factors for adverse events associated with orthopaedic surgeries as captured within a common clinical point-of-care system for documenting adverse events (Orthopaedic Surgical AdVerse Events Severity [OrthoSAVES] system)...
August 16, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28816851/clinical-practice-guideline-safe-medication-use-in-the-icu
#15
Sandra L Kane-Gill, Joseph F Dasta, Mitchell S Buckley, Sandeep Devabhakthuni, Michael Liu, Henry Cohen, Elisabeth L George, Anne S Pohlman, Swati Agarwal, Elizabeth A Henneman, Sharon M Bejian, Sean M Berenholtz, Jodie L Pepin, Mathew C Scanlon, Brian S Smith
OBJECTIVE: To provide ICU clinicians with evidence-based guidance on safe medication use practices for the critically ill. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and ISI Web of Science for relevant material to December 2015. STUDY SELECTION: Based on three key components: 1) environment and patients, 2) the medication use process, and 3) the patient safety surveillance system...
September 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28816536/optimizing-lenvatinib-therapy-in-patients-with-metastatic-radioactive-iodine-resistant-differentiated-thyroid-cancers
#16
Sina Jasim, Nicole M Iniguez-Ariza, Crystal R Hilger, Ashish V Chintakuntlawar, Mabel M Ryder, John C Morris, Keith C Bible
BACKGROUND AND OBJECTIVES: Lenvatinib is approved for use in advanced radioactive iodine resistant differentiated thyroid cancers (RAIR-DTCs); its efficacy is indisputable, but toxicities are great, creating daunting challenges for patients and providers. Few data regarding early adverse events and impact on quality of life (QOL) exist; we sought to add clarity to these issues by analyzing our initial post-approval lenvatinib experience. METHODS: Standardized patient education was implemented, providing detailed instructions and expert provider contacts to facilitate timely reporting of toxicities and guide responsive actions...
August 17, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28816346/homocysteine-lowering-interventions-for-preventing-cardiovascular-events
#17
REVIEW
Arturo J Martí-Carvajal, Ivan Solà, Dimitrios Lathyris, Mark Dayer
BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated...
August 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28816242/effect-of-the-mglur5-nam-basimglurant-on-behavior-in-adolescents-and-adults-with-fragile-x-syndrome-in-a-randomized-double-blind-placebo-controlled-trial-fragxis-phase-2-results
#18
Eriene A Youssef, Elizabeth Berry-Kravis, Christian Czech, Randi J Hagerman, David Hessl, Chin Y Wong, Michael Rabbia, Dennis Deptula, Amy John, Russell Kinch, Philip Drewitt, Lothar Lindemann, Moritz Marcinowski, Rachel Langland, Carsten Horn, Paulo Fontoura, Luca Santarelli, Jorge A Quiroz
Preclinical data suggests that inhibition of the mGluR5 receptor might hold therapeutic benefits in Fragile X syndrome (FXS). Treatment of Fmr1 knockout mice with mGluR5-negative allosteric modulators (NAMs) has been reported to correct a broad range of phenotypes related to FXS. The early short-term clinical trials with mGluR5 NAMs, including basimglurant, assessing the effects in individuals with FXS, were supportive of further exploration in larger, well-controlled trials. We evaluated basimglurant, a potent and selective mGluR5 NAM, in a 12-week, double-blind, parallel-group study of 183 adults and adolescents (aged 14-50, mean 23...
August 17, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28815800/a-method-for-data-driven-exploration-to-pinpoint-key-features-in-medical-data-and-facilitate-expert-review
#19
Kristina Juhlin, Kristina Star, G Niklas Norén
PURPOSE: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815660/absorption-and-tolerability-of-taste-masked-hydrocortisone-granules-in-neonates-infants-and-children-under-6-years-of-age-with-adrenal-insufficiency
#20
Uta Neumann, Martin J Whitaker, Susanna Wiegand, Heiko Krude, John Porter, Madhu Davies, Dena Digweed, Bernard Voet, Richard J Ross, Oliver Blankenstein
OBJECTIVES: There is no licensed, dose-appropriate formulation of hydrocortisone for children with adrenal insufficiency (AI) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort(®) , an immediate-release, granule formulation of hydrocortisone with taste masking. STUDY DESIGN: Single site with satellites attended by a "flying" doctor from investigator site. Open-label, single-dose study in three consecutive child cohorts (n=24) with AI; Cohort 1, children aged 2 to <6 years (n=12); Cohort 2, infants aged 28 days to <2 years (n=6); Cohort 3, neonates aged 1 to <28 days (n=6)...
August 16, 2017: Clinical Endocrinology
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